FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

PPTA News

Final Summary of the PPTA/FDA Liaison Meeting on September 14, 2022 +

The following is a final summary of the PPTA-FDA Liaison Meeting held virtually on September 14, 2022.

Welcome, Introductions & Meeting Guidelines

PPTA and Head of Global Plasma welcomed all participants and appreciated FDA’s participation in today’s meeting. PPTA’s Head of Global Regulatory Policy opened the meeting with introductory remarks. PPTA’s External Legal Counsel advised the participants on the meeting guidelines and the antitrust statement.
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International Plasma Awareness Week 2022: Donate Locally. Think Globally. +

ANNAPOLIS, MD (October 3, 2022) — The Plasma Protein Therapeutics Association (PPTA) is proud to mark the launch of the 10th annual International Plasma Awareness Week (IPAW), which will run from Monday, October 3 until Friday, October 7. Hundreds of thousands of people in the U.S. who live with these rare diseases, and countless others facing trauma and emergency medical needs every day, rely on plasma-derived therapies that are only available because of the commitment of dedicated plasma donors.
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HHS Launches Plasma and Blood Donation Campaign +

On August 4, the U.S. Department of Health and Human Services (HHS) launched a new nationwide campaign, Giving=Living, intended to draw awareness to the importance of plasma and blood donation, especially following a steep decline in both caused by the Covid pandemic.
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PPTA Statement on the draft EU Substances of Human Origin Regulation +

PPTA welcomes positive developments but regrets missed opportunities to support plasma donors and patients who rely on plasma-derived medicinal products (PDMPs)

Brussels, Belgium (July 14, 2022). While the text of the draft regulation on Substances of Human Origin (SoHo) addresses a number of PPTA’s concerns, it has missed the opportunity to help Member States increase plasma collection to improve the reliable availability of life-saving, plasma-derived therapies to patients with a wide range of rare and complex, chronic diseases. As much as 38% of the plasma used to produce medicines for the EU’s 300,000 rare disease patients who rely on PDMPs comes from the U.S., a reliance highlighted during the pandemic, when critical plasma donations declined significantly.
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"How Is Your Day?" is an initiative to raise awareness of the unique nature of plasma protein therapies and the value they provide to patients. It aims to inform and educate decision makers and the general public worldwide.

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FDA Launches New Quality/Compliance Web Content

Final Summary of the PPTA/FDA Liaison Meeting on September 14, 2022 +

International Plasma Awareness Week 2022: Donate Locally. Think Globally. +

HHS Launches Plasma and Blood Donation Campaign +

PPTA Statement on the draft EU Substances of Human Origin Regulation +

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